MAUDE Adverse Event Report: INFANT BREATHING CIRCUIT; BTT

Model Number RT228

Device Problems Mechanical Problem (1384); Incorrect, Inadequate or Imprecise Result or Readings (1535)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 01/20/2021

Event Type  malfunction  

Manufacturer Narrative

The rt228 infant breathing circuit is not sold in the usa but is similar to a device that is sold in the usa.The 510(k) for the similar device is k020332.(b)(4).The complaint rt228 infant breathing circuit is expected but has not yet returned to f&p (b)(6) for evaluation.We will provide a follow-up report upon completion of our investigation.

Event Description

A distributor in (b)(6) reported on behalf of a healthcare facility via a fisher & paykel healthcare (f&p) field representative that a rt228 infant breathing circuit failed a ventilator pressure test before use.It was also reported that the restrictor of the breathing circuit was blocked.There was no patient involvement.

Event Description

A distributor in japan reported on behalf of a healthcare facility via a fisher & paykel healthcare (f&p) field representative that a rt228 infant breathing circuit failed a ventilator pressure test before use.It was also reported that the restrictor of the breathing circuit was blocked.There was no patient involvement.

Manufacturer Narrative

G4: the rt228 infant breathing circuit is not sold in the usa but is similar to a device that is sold in the usa.The 510(k) for the similar device is k020332.(b)(4).Method: the complaint (b)(4) infant breathing circuit was returned to fisher & paykel healthcare (f&p) in new zealand for evaluation, where it was visually inspected.Results: visual inspection revealed a flash at the orifice on the restrictor of the subject breathing circuit.Conclusion: the flash at the office of the restrictor of the subject breathing circuit was likely caused by a moulding defect.The sle restrictors of the rt228 infant breathing circuits are sampled and visually inspected during production.All infant breathing circuits are visually inspected and pressure and flow tested during production, and those that fail are rejected.The user instructions that accompany the rt228 infant breathing circuit state the following: check all connections are tight before use.Ensure appropriate venitlator or flow source alarms are set before connecting breathing set to patient.Perform a pressure and leak test on the breathing system and check for occlusions before connection to a patient.Appropriate patient monitoring must be used at all times.Failure to monitor the patient may result in serious harm or death.

• Brand Name: INFANT BREATHING CIRCUIT
• Type of Device: BTT
• MDR Report Key: 11383098
• MDR Text Key: 242450207
• Report Number: 9611451-2021-00215
• Device Sequence Number: 1
• Product Code: BTT
• Combination Product (y/n): N
• PMA/PMN Number: SEE H10
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,distri
• Type of Report: Initial,Followup
• Report Date: 01/27/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: RT228
• Device Catalogue Number: RT228
• Device Lot Number: NOT PROVIDED
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/15/2021
• Initial Date Manufacturer Received: 01/27/2021
• Initial Date FDA Received: 02/25/2021
• Supplement Dates Manufacturer Received: 05/09/2021
• Supplement Dates FDA Received: 06/07/2021
• Was Device Evaluated by Manufacturer?: Yes
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Treatment: F&P MR850 RESPIRATORY HUMIDIFIER; F&P MR850 RESPIRATORY HUMIDIFIER; SLE6000 VENTILATOR; SLE6000 VENTILATOR